510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,618

176,415 records, page 2958 of 3529

510(k) clearances, page 2958 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853644	Nitto Surgical Plastic Tape St-356	Nitto Denko America, Inc.	KGX	Class I	1985-09-19
K853600	Inflatable Air Splints	Hospitak, Inc.	FZF	Class I	1985-09-19
K853551	Ysi Model 790 Tele-Thermometer	Yellow Springs Instrument Co., Inc.	FLL	Class II	1985-09-19
K853456	Phadebas Rast/phadezym Rast Allertubes	Pharmacia, Inc.	DHB	Class II	1985-09-19
K853421	The Keymed Vari-Height Patient Couch	Keymed, Inc.	FPO	Class II	1985-09-19
K853378	Auto Pro	Respiration Technology, Inc.	NFB	Class II	1985-09-19
K853319	Mini-Halo(hand-Held) CO2 Laser System	Directed Energy, Inc.	GEX	Class II	1985-09-19
K853212	Flow Ease(plastic Vented Needle)	Acacia, Inc.	LHI	Class II	1985-09-19
K853122	Immuno-Prod Ind Fluore Trepone Antibody Absorped	Immuno-Products Industries	GMS	Class II	1985-09-19
K852996	Dyna Gard Syringe Filter	Microgon, Inc.	FPB	Class II	1985-09-19
K852907	Siemens Mevatron Me	Siemens Medical Laboratories, Inc.	LHN	Class II	1985-09-19
K852869	Selecticult-Chlamydia	Scott Laboratories, Inc.	LKH	Class I	1985-09-19
K852831	Non-Kor Access Kits	Creative Care Systems, Inc.	FMI	Class II	1985-09-19
K852801	Biochron Fertility Indicator	Fertil-A-Chron, Inc.	LHD	Unclassified	1985-09-19
K852794	Allercoat Allergen Discs	Kallestad Laboratories, Inc.	DHB	Class II	1985-09-19
K852768	Oralix Panoramic D.c.	Philips North America LLC	IZF	Class II	1985-09-19
K852750	Tegaderm Plus Transparent Dressing #952X	3M Company	FRO	Unclassified	1985-09-19
K852696	For Use in General & Plastic Surgery & Dermatology	Minnesota Laser Corp.	GEX	Class II	1985-09-19
K852606	Fleboset 1401(60 Drops/mi) and Fleboset1400(20)	Infarkem Corp.	FPA	Class II	1985-09-19
K852572	3.5 Mhz Cw Doppler Probe Model No. 8421802	Siemens Medical Solutions USA, Inc.	JAF	Class II	1985-09-19
K852571	3.5 Mhz Linear Array, Model No. 83, 39, 509	Siemens Medical Solutions USA, Inc.	IYO	Class II	1985-09-19
K852570	5.0 Mhz Linear Array, Model 83, 39, 517	Siemens Medical Solutions USA, Inc.	IYO	Class II	1985-09-19
K852487	Fukuda Denshi Model Au-5001-5003 Thermal	Fukuda Denshi USA, Inc.	DSF	Class I	1985-09-19
K851828	Irradiator for Biological Materials Ibl-437-C	Syncor Intl. Corp.	MOT	Unclassified	1985-09-19
K851807	Rt2600(115v)(220/240v) #H4008a & H4008ae	General Electric Co.	IYO	Class II	1985-09-19
K850761	Model Pcx/emy 525A Microprocesssor Control X-Ray C	Medicor USA, Ltd.	BZN	Class I	1985-09-19
K844319	Km-2 Metal-Backed Acetabular Cup	Kirschner Medical Corp.	JDI	Class II	1985-09-19
K853628	Simultrac Free T4(57co)/tsh[125i] Radioimmunoassay	BD Becton Dickinson Vacutainer Systems Preanalytic	CEC	Class II	1985-09-18
K853548	Stratus Procainamide Fluorometric Enzyme Immunoass	American Dade	LCM	Unclassified	1985-09-18
K853371	H-H Atrial Catheters & Peritoneal Catheters	Holter-Hausner Intl.	JXG	Class II	1985-09-18
K853370	H-H Catheter Passers(tacl Design	Holter-Hausner Intl.	GYK	Class I	1985-09-18
K853303	Lifelinc Leadwire	Tronomed, Inc.	BZQ	Class II	1985-09-18
K853014	Mcghan Tissue Expander Fill Kit	Mcghan Medical Corp.	LCJ	Unclassified	1985-09-18
K852736	Baylor Rapid Autotransfusion System	Cardio Systems, Inc.	CAC	Class II	1985-09-18
K852687	Algo I	Algotek, Inc.	GWJ	Class II	1985-09-18
K852639	Humphrey Field Analyzer Model 630	Zeiss Humphrey System	HPT	Class I	1985-09-18
K852629	Aero-Mask Two	Ashai Co., Ltd.	BYG	Class I	1985-09-18
K852628	Nasal One	Ashai Co., Ltd.	CAT	Class I	1985-09-18
K852626	Aero-Mask One	Ashai Co., Ltd.	BYG	Class I	1985-09-18
K852625	Oxy-Tube	Ashai Co., Ltd.	CAT	Class I	1985-09-18
K852624	Oxy-Two	Ashai Co., Ltd.	BYG	Class I	1985-09-18
K852623	Oxy-One	Ashai Co., Ltd.	BYG	Class I	1985-09-18
K852618	Oxy-Dial	Ashai Co., Ltd.	BYF	Class I	1985-09-18
K852517	Cls Hip Prosthesis	Advanced Biosearch Assn.	JDI	Class II	1985-09-18
K852108	Newport Ventilator Model E-100	Newport Medical Instruments, Inc.			1985-09-18
K851640	Tip Toledo Incisor Protector	Edward O. Goodwich	BRW	Class I	1985-09-18
K851422	S-Rom 135 Femoral Stem & Collar(part of S-Rom Hip	Joint Medical Products Corp.	JDI	Class II	1985-09-18
K853691	Tergitol 7 Agar	Micro Media Laboratories	JSI	Class I	1985-09-17
K853690	Columbiz Blood Agar	Micro Media Laboratories	JSG	Class I	1985-09-17
K853223	Slimline Unipolar Endocardial Pacing Lead, #30-407	Telectronics, Inc.	DTB	Class III	1985-09-17